Coma Family Program for Caregiver Resilience
(COMA-F Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assist caregivers of patients with severe acute brain injuries by testing two programs designed to support mental health. The first program, Coma Family Program 1, teaches skills for managing stress and long-term caregiving challenges. The second, Coma Family Program 2, provides education on handling these issues. The trial seeks caregivers experiencing significant emotional distress who are the primary support for a loved one in the ICU with a severe brain injury. As an unphased trial, it offers caregivers the chance to access potentially beneficial support programs tailored to their unique challenges.
What prior data suggests that these psychosocial programs are safe for caregivers?
Research shows that the Coma Family Program 1, which teaches skills to manage stress and caregiving challenges, receives positive feedback from participants. In past studies, caregivers in similar programs felt more resilient and better equipped to handle stress. No major reports of negative effects or issues have emerged from these programs. This suggests that the program is safe for caregivers seeking to improve their mental health while supporting loved ones with severe brain injuries.12345
Why are researchers excited about this trial?
Researchers are excited about the Coma Family Program for Caregiver Resilience because it offers a new way to support those caring for loved ones in a coma. Unlike typical support options that may focus solely on education, this program provides hands-on skills training to effectively manage distress and uncertainty. By equipping caregivers with practical tools, the program aims to reduce burnout and improve long-term resilience. This approach represents a shift towards proactive caregiver support, which could significantly enhance the well-being of both caregivers and patients.
What evidence suggests that this trial's programs could be effective for improving caregiver mental health?
Research shows that the Coma Family Program 1, available to participants in this trial, helps caregivers manage stress and enhance coping skills. Studies have found that this program reduces emotional stress and increases mindfulness, which involves focusing on the present moment without judgment. In a small study, caregivers reported feeling less emotional distress after participating in the program. It teaches skills like deep breathing and meditation, which assist with the challenges of long-term caregiving. Overall, the Coma Family Program 1 appears promising in supporting caregivers' mental health.12467
Are You a Good Fit for This Trial?
This trial is for caregivers aged 18 or older who speak English and are experiencing emotional distress while caring for patients with severe acute brain injuries. Patients must have a Glasgow Coma Scale score below 9, be alive in ICU, and expected to survive more than 3 months without terminal illness.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive psychosocial programs aimed at improving caregiver mental health
Follow-up
Participants are monitored for mental health outcomes and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Coma Family Program 1
- Coma Family Program 2
Trial Overview
The study compares two psychosocial programs designed to support mental health among caregivers of coma or severe brain injury patients. It aims to determine if these programs can improve resilience and reduce caregiver burden.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
A Mindfulness-Based Resiliency Program for Caregivers of ...
During the intervention we will teach caregivers mind-body and resilience skills, including deep breathing, mindfulness, meditation, dialectical ...
The COMA Family Program: A Skills-Based Resiliency ...
The main intervention goal is to provide dyads with resiliency skills to reduce emotional distress and prevent chronic distress. Intervention/Treatment ...
Multisite Open Pilot Trial of a Resilience Intervention for ...
COMA-F exceeded feasibility and acceptability benchmarks (≥ 70% on all) and showed improvements in emotional distress, dispositional mindfulness ...
Skills-Based Resiliency Program for Caregivers of Coma ...
Studies have found that this program lowers emotional stress and improves coping skills. A small initial study showed promising results, with caregivers ...
A Mindfulness-Based Resiliency Program for Caregivers of ...
During the intervention we will teach caregivers mind-body and resilience skills, including deep breathing, mindfulness, meditation, dialectical thinking, ...
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ctv.veeva.com
ctv.veeva.com/study/the-coma-family-program-coma-f-a-resilience-program-for-caregivers-of-patients-with-severe-acuteA Resilience Program for Caregivers of Patients With Severe ...
This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges. Treatment: Behavioral: Coma Family ...
Relationships among Demographic, Clinical, and ...
Before effectively engaging family members in patient care, clinicians must assess characteristics and circumstances that may affect caregiver ...
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